Medical Technology
Medical Technology
Safety, Quality, Approval.
The development of modern medical devices requires safety, quality, and regulatory diligence.
FSQ-Experts supports medtech companies from concept to market entry.
Current Challenges
“We know we need a QMS—but we don’t want a bureaucratic nightmare.”
“We have a great product—but we don’t know how to bring it to Europe, the U.S., and China.”
"We're working flat out on development—but our risk management documentation is lagging behind."
What Our Customers Say
Structured Approach
From in-depth analysis to successful validation, we provide structured support throughout all project phases—or offer targeted assistance at specific stages.
1
Analysis
Requirements analysis and development of customized solutions.
2
Concept &
Implementation
Development of concepts, identification of vulnerabilities and risks.
3
Validation &
Assessment
Ongoing validation to improve product safety.
Our Expertise
How to achieve your goals with FSQ Experts:
Expertise with in-depth technical knowledge
Our experts hold engineering degrees and understand the complex technical requirements of medical devices—ensuring you receive tailored advice.
ISO 13485
Expertise
Support for audits and certifications
Whether it's ISO 13485 or the MDR, we provide comprehensive audit preparation and support for regulatory compliance.
Audit
MDR
Proven solutions for market authorization
Our consulting services cover regulatory strategies, technical documentation, and post-market surveillance to ensure long-term market success.
ISO 13485
Expertise
Risk Management & Development Support
We facilitate risk management workshops and support you throughout the entire development cycle—from requirements to verification.
Risikomanagement
ISO 13485
Support for ISO 13485-compliant QMS
We can help you develop and implement a quality management system tailored specifically to the medical technology industry—from startups to mid-sized companies.
QMS
ISO 13485
Agile Processes with EchoScrum
With our EchoScrum methodology, we efficiently integrate quality and safety requirements into your development processes
Agile
ISO 13485
Direct, collaborative, and on equal footing
Our communication is clear, solution-oriented, and technically sound. We speak the same language as your developers—and your auditors.
ISO 13485
Expertise
Let's talk about your project!
Schedule a no-obligation consultation with our experts now
Unsere Lösungen
Mit unseren Lösungen schaffen Sie die Grundlage für robuste Prozesse, sichere Produkte und nachhaltigen Markterfolg – effizient, praxisnah und partnerschaftlich.
Effiziente Compliance
Beschleunigter Marktzugang
Adaptive Prozesse
Produkt-Safety & Security
Sicherheit System of Systems
Success Story
Approval of AI-based medical devices
The Current Situation
Integrating AI capabilities into existing software: What are the international regulatory and clinical requirements—and what risks are involved?
The Challenge
The regulatory framework for AI in medical technology is complex; an international strategy is necessary.
The Solution
During workshops, a pre-regulatory and clinical strategy incorporating AI-specific requirements in the target markets was developed, and initial technical documentation and clinical strategies were prepared.
Customer Benefits
- Guidance on regulatory requirements
- A basis for decision-making in AI development
- Integration of products into EU processes
- MDR-compliant technical documentation
- Efficient international collaboration
- CE marking without delays
Sprechen wir über Ihr Projekt!
Vereinbaren Sie jetzt ein unverbindliches Beratungsgespräch mit unseren Expert:innen
Success Story
MDR Compliance: US Products Ready for the EU Market
The Initial Situation
A German medtech company acquired a U.S. manufacturer with FDA-approved products.
The Challenge
Two companies, two continents, two systems - and one ambitious goal: seamless product integration into EU processes and MDR certification without any delay.
The Solution
FSQ-Experts was directly integrated into the project. Thanks to our long-standing collaboration with the German parent company, we were thoroughly familiar with their quality management system (QMS), development processes, and documentation structure. We served as the liaison between the teams.
Customer Benefits
- Seamless integration of the acquired products into existing EU processes
- Fully MDR-compliant technical documentation
- Effective collaboration between the U.S. and German teams
- Successful CE certification process - with an experienced and trusted partner by your side
Success Story
Erfolgreicher Marktzugang in China
The Initial Situation
A manufacturer of surgical microscopes for ophthalmology was planning to enter the Chinese market. Although the product was already CE-certified, the Chinese regulatory authority, the NMPA, required additional testing. The key question was: Should the device be shipped to China for type testing—or would it be more efficient to bring Chinese auditors to Germany?
The Challenge
New regulatory requirements, language barriers, and a complex approval process presented the team with significant uncertainties. Without local knowledge and precise planning, delays and high costs loomed.
The Solution with FSQ Experts
FSQ Experts assembled a dedicated regulatory affairs team comprised of native Chinese speakers, who worked closely with the client over a six-month period.
Our Services
- Coordination of all communications with Chinese authorities and testing laboratories
- Alignment of the testing strategy with NMPA requirements
- Organization and execution of testing directly at the client’s site in Germany
- On-site support from our experts throughout all testing phases
Customer Benefits
- Regulatory clarity from the start
- Efficient testing process conducted in-house
- Early submission to the NMPA - ahead of the originally scheduled deadline
- Smooth approval process thanks to accurate and complete documentation (including PTR)
Sprechen wir über Ihr Projekt!
Vereinbaren Sie jetzt ein unverbindliches Beratungsgespräch mit unseren Expert:innen